A Bicycle Training Intervention

NCT02046889 | Completed

• 2 other identifiers: CMBDS2012H133G090006
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

Brief Summary

The objectives of this study are to 1) demonstrate the effectiveness of the innovative bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel bike, and 2) determine the effects of the treatment on health related performance measures, physical activity level, patterns of sleep behavior, psychosocial outcomes, and community participation. The hypotheses to be tested in this study are: 1) there will be a significant treatment group difference (EXP vs CON) in the number of participants who demonstrate the ability to ride a two wheel bicycle in favor of the EXP group following the first year of training. 2) At the end of the second year of training when the CON group receives the bicycle training program, there will not be a group difference in the number of riders who learned to ride. 3) At the end of the first year, there will be a significant treatment group difference (EXP vs CON) on the health related performance measures, average time spent in moderate and moderate to vigorous physical activity, patterns of sleep behavior (sleep onset, frequency of night waking), self and parent perceptions of bicycle riding ability, and community participation (number of community activities engaged in, frequency of community participation, number of people they participate with outside of the parents, the number of community locations in which they participate), in favor of the EXP group. 4) At the end of the second and third year, the CON group will demonstrate a significant improvement in all of these measures (a significant improvement from the pre-training measures to the 12 and 24 month measures). 5) At the end of the third year, the EXP group will demonstrate a significant group difference on all measures compared to the CON group but the magnitude of the difference will be less than was observed in hypothesis 3 at the 12 month measurement before the CON group received their training. These hypotheses will be tested separately for the DS and ASD groups.

Conditions

Autism Spectrum Disorder; Down Syndrome

Outcome Measures

Primary Outcomes (4)

• Independent bicycle riding ability

  Participants will be assessed on their ability to independently ride a two-wheeled bicycle at least 100 feet at the conclusion of the 5 day/75 minutes per day intervention.

  End of 5 day intervention

• Bicycle riding effects on physical activity

  Participants will be monitored following learning to ride a two-wheeled bicycle to see if the skill impacts their daily habitual physical activity levels

  1 and 2 years following intervention

• Bicycle riding effects on leg strength

  Participants will have their isometric leg strength measured following learning to ride a two-wheels bicycle to see if the skill impacts muscular strength

  1 and 2 years following intervention

• Bicycle riding effects on static balance ability

  Participants will have their static balance ability assessed following learning to ride a two-wheeled bicycle to see if the skill impacts balance ability.

  1 and 2 years following intervention

Secondary Outcomes (2)

• Participation following learning to ride a two-wheeled bicycle

  1 and 2 years following intervention

• Bicycle riding effects on sleep behavior

  1 and 2 years following the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group or experimental group will receive the bicycle training intervention during the first year of the study. The intervention is a 5 day/75 minutes per day bicycle training intervention which used specialized instruction and adapted equipment to teach independent bicycle riding skills to youth aged 9-18 years with autism spectrum disorder and Down syndrome.

Behavioral: Bicycle Training Intervention

Control group

NO INTERVENTION

The control group will not receive the intervention during the first year of the study. Instead, this group will receive a delayed intervention during the second year of the study, after pre-post effects have been evaluated.

Interventions

Bicycle Training Intervention BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with Autism spectrum disorder or Down syndrome
• Aged 9-18 years at entry into study
• Cannot independently ride a two-wheeled bicycle

You may not qualify if:

• Having a condition which would be a safety risk on a bicycle or performing physical activity, including but not limited to a seizure disorder or mobility issue.
• Weighing more than 250 lbs which is the maximum weight allowance for the equipment used during the intervention.

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Unknown Facility

Southbend, Indiana, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Grand Rapids, Michigan, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Down Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Dale A Ulrich, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: January 28, 2014
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

US (3)